Kornimate/medical-research-clean huggingface dataset:
docosahexaenoic acid (dha) administration and length of gestation: a feasibility study

Conditions: Premature Birth

Summary: this is a feasibility study to determine if it will be possible to conduct a larger study of the effect of docosahexaenoic acid (dha), an omega fatty acid, on increased length of gestation among women who have had a previous preterm delivery.

we propose to conduct an 18-month feasibility study to determine (a) how many women we could approach during a 4-month period, (b) how many of these women would be eligible for a future rct, (c) how many would consent to participate in the rct, and (d) how many would be subsequently rendered ineligible due to poor compliance. women enrolled during the 4-month recruitment period would be followed until 1 month after delivery using telephone contact (for assessing compliance) and scanning of kpmcp electronic databases (for quantifying outcomes). we hope to enroll 50 to 75 women during our fixed time (4 months) recruitment period. half of these 50-75 women would receive dha; half would receive placebo. we will identify potential subjects based on their response to the preterm birth prevention program questionnaire (a screening instrument administered by the regional perinatal service center \[rpsc\] to all women in the kpmcp entering prenatal care). eligible women are those pregnant women entering prenatal care who, based on their response to the abovementioned rpsc questionnaire, are identified as having had a previous preterm delivery (delivery prior to 37 completed weeks of gestation). results of this study will (a) permit us to determine whether an rct is feasible at a reasonable cost, and (b) assuming the answer to (a) is positive, it would then be possible for us to design an rct that could address our primary study question.

Eligibility criteria:
inclusion criteria: * previous preterm delivery (delivery prior to 37 completed weeks of gestation) exclusion criteria: * none

Keywords: perinatal premature pregnancy gestation
marlina - t2d : efficacy, safety & modification of albuminuria in type 2 diabetes subjects with renal disease with linagliptin

Conditions: Diabetes Mellitus, Type 2

Summary: evaluate linagliptin in terms of glycemic control as defined by hba1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (uacr) after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * glycosylated hemoglobin (hba1c) between 6.5 and 10% (inclusive) * current therapy with acei or arb at stable dose for 10 weeks * urinary albumin-to-creatinine ratio (uacr): 30-3000 mg/g creatinine documented in the previous 12 months or detected at screening. * estimated glomerular filtration rate (egfr) greater than 30 ml/min. * age between 18 and 80 years. exclusion criteria: * dual or triple blockade of the renin angiotensin system (ras) * uncontrolled hyperglycaemia * mean arterial blood pressure \> 110 mmhg * known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos). * treatment with a glitazone within 6 months prior to informed consent. * treatment with a dipeptidyl-peptidase 4 (dpp-4) inhibitor, a glucagon like peptide-1 (glp-1) agonist, a sodium/glucose cotransporter 2 (sglt2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent. * treatment with anti-obesity drugs 10 weeks prior to informed consent. * alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator. * current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. * participation in another trial with an investigational drug within 2 months prior to informed consent.
smartphone technology: young adult drinking

Conditions: Alcohol Use; Alcohol Drinking; Drinking Behavior

Summary: exploring technology based tools to reduce drinking is important. the purpose of this research study is to compare different bac monitoring apps for their effects on alcohol drinking and ratings of usability among young adults.this study will be conducted in six phases: a web-based and in-person screening assessment; brief counseling session on the day before the alcohol drinking session; brief appointment on the day of the alcohol drinking session; alcohol drinking session; two-week field period; and a follow-up appointment. participation in this study will last approximately two months.


Eligibility criteria:
inclusion criteria: * be able to read/write english and complete study assessments * drink alcohol regularly exclusion criteria: * test positive on a urine test for use of certain illegal drugs * undergraduate student enrolled at the university of florida * graduate students from the college of health and human performance at the university of florida * pregnant, or currently breast feeding

Keywords: brief intervention harm reduction young adult college student
rhdnase eye drops in patients with ocular graft-vs.-host disease

Conditions: Ocular Graft vs Host Disease; Dry Eye

Summary: the purpose of this study is to evaluate the tolerability and preliminary efficacy of rhdnase i eye drops in patients with ocular graft-vs.-host disease (ogvhd).


Eligibility criteria:
inclusion criteria: * the pi and other members of international chronic ocular gvhd consensus group have established the consensus diagnostic criteria and classification for chronic ocular gvhd. table 1: severity scale in chronic ocular gvhd severity scores (points) schirmer's test (mm) cfs (points) osdi (points) conj (points) 0 \>15 0 \<13 none 1. 11-15 \<2 13-22 mild/moderate 2. 6-10 2-3 23-32 severe 3. ≤5 ≥4 ≥33 cfs; corneal fluorescein staining, osdi; ocular surface disease index. conj; conjunctival injection. severity classification; total score (points); (schirmer's test score+ cfs score+ osdi score+ conj injection score) = none;0-4, mild/moderate; 5-8, severe, 9-11. table 2: diagnosis of chronic ocular gvhd none (points) probable gvhd (points) definite gvhd (points) systemic gvhd(-) 0-5 6-7 ≥8 systemic gvhd(+) 0-3 4-5 ≥6 based on these criteria (tables 1 and 2),40 patients with definite ocular gvhd will be enrolled. additionally, all of the following criteria should be met to be eligible for the study: * aged 18 years or older. * capable of giving informed consent and does provide informed consent. * schirmer i \<10 * corneal/ conjunctival (rose bengal) staining ≥1 * ocular symptoms must be considered as annoying or activity limiting (osdi ≥13; mild). * women must be post-menopausal ≥ 1 year, or surgically sterilized. if not, a negative urine pregnancy test is required within 14 days of receiving her first dose of test medication (placebo/ study drug) along with definite evidence of contraceptive use during the duration of the study. women of reproductive age should use a method of birth control that is acceptable to the subject and the study doctor. this may include oral contraceptive pills, birth control implants, barrier methods or abstinence. if a subject mentions she suspects she may be pregnant after being enrolled, another pregnancy test will be administered. if the test is positive, she will be discontinued from the study immediately. exclusion criteria: * subjects will not be eligible for the study if any of the following criteria are met: * allergic to rhdnase i or any similar products, or recipient of rhdnase i eye drops 0.1%. * receiving or have received within 30 days any experimental systemic medication. * active ocular infection or ocular allergies. * any history of eyelid surgery or ocular surgery within the past 3 months. * corneal epithelial defect larger than 1 mm2 in either eye. * have active drug/alcohol dependence or abuse history. * vulnerable populations, such as neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations.

Keywords: rhdnase i, pulmozyme, ogvhd, dry eye
combined application of pulsed rf and steroids to the drg for phn

Conditions: Postherpetic Neuralgia; Chronic Pain

Summary: recently, the use of pulsed radiofrequency has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. we hypothesize that the combined use of pulsed rf and steroid injection applied to the drg may achieve better outcomes than the use of epidural steroid injection alone.

varicella-zoster virus reactivates in sensory ganglia as the dorsal root ganglion (drg). the drg contains many receptor channels and is an important region for pain signal transduction. sustained abnormal electrical activity to the spinal cord via the drg in acute herpes zoster can result in neuropathic conditions such as postherpetic neuralgia (phn). postherpetic neuralgia (phn) is the final stage of varicella-zoster infection and is manifested as severe refractory neuropathic pain. preventing the transition of herpes zoster-related pain to phn is a very important therapeutic principle for patients at an early stage, especially for older patients. the exact discriminative time point for phn has not yet been standardized. various criteria have been used, from 30 days to 180 days after zoster onset. if pain persists for more than 180 days after zoster onset, the likelihood of pain reduction is very low and such a condition is considered "well established" phn. therefore, it is advisable to actively attempt various treatment modalities for pain control before the condition progresses to a recalcitrant state. pulsed radiofrequency (prf) is a variant of thermal radiofrequency that applies pulsed current to limit heat generation to less than 42˚c, creating a little risk of thermal or nerve injury. recently, the use of prf has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. we hypothesize that combined use of pulsed rf and steroid injection applied to the drg may achieve a better outcome than use of epidural steroid injection alone.

Eligibility criteria:
inclusion criteria: * patients with asa i\&ii status * thoracic zoster related pain * less than three months duration from the appearance of shingles exclusion criteria: * coagulopathy * local infection * patient refusal * diabetes melliteus
application of cielab spectrophotometry to analyze gingival color: a new perspective for evaluating the effectiveness of periodontal basic treatment

Conditions: Periodontitis

Summary: objective: this study aims to explore the correlation between gingival color and clinical indicators and inflammatory factors in patients with periodontitis. method: this study aims to include 30 periodontitis patients who visited the periodontology department of the second affiliated hospital of zhejiang university school of medicine from october 2024 to november 2024. the study adopted a self controlled before and after design. all subjects received periodontal basic treatment. record the age, gender, ethnicity, skin color, and gingival biotype of the subjects. before treatment, 6 weeks after treatment, and 12 weeks after treatment, check and record the blood routine, high-sensitivity c-reactive protein (hs crp), and interleukin-6 (il-6) of all subjects. use a moisture absorbing paper tip to collect the gingival crevicular fluid of the subjects, and further detect the levels of interleukin-17 (il-17) and tumor necrosis factor alpha (tnf - α) in the gingival crevicular fluid samples, and record the periodontal table. check and record the cie indicators l \*, a \*, b \*, probing depth (pd), gingival bleeding index (sbi), and clinical attachment loss (cal) in the keratinized gingival area of all subjects before and after treatment at 2, 6, and 12 weeks. analyze and compare the changes in each group's data before and after treatment.


Eligibility criteria:
inclusion criteria: 1. patients of han ethnicity, aged between 18 and 65 years old, diagnosed with periodontitis 2. i haven't received any periodontal basic treatment, including scaling, scraping, flap surgery, etc., for the past six months 3. the anterior teeth area has not undergone periodontal surgery or coronal restoration within six months 4. the patient has clear thinking, unobstructed communication, and high compliance exclusion criteria: 1. cardiac function levels iii and iv 2. blood pressure\>180/110 mmhg 3. pregnant women, women in pregnancy or lactation 4. those who are currently taking anticoagulant drugs, calcium channel blockers, immunosuppressants, angiotensin and other medications, receiving bisphosphonates treatment, or have a history of antibacterial treatment within 3 months 5. uncontrolled and stable patients with systemic diseases, such as progressive liver diseases, infectious diseases, renal failure, rheumatoid diseases, blood system diseases, osteoporosis, aids, mental diseases and diabetes, etc 6. patients with malignant tumors or undergoing radiotherapy, chemotherapy, and targeted drug therapy 7. patients with pacemakers who cannot undergo ultrasound therapy 8. smoking or quitting smoking for less than 5 years 9. individuals with abnormalities such as pigment deposition and keratinized beads in the front teeth and gums

Keywords: periodontitis periodontal basic treatment spectrophotometer colorimeter
pediatric advair diskus versus oral montelukast chewable tablets

Conditions: Asthma

Summary: this study is being conducted to demonstrate the superior clinical effectiveness of salmeterol/fluticasone propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment \[salmeterol/fluticasone propionate (50/100 mcg) and montelukast (5 mg)\] on lung function, asthma control, health outcomes including the child's quality of life as measured by paediatric asthma quality of life questionnaire (paqlq) and the caregiver's quality of life as measured by paediatric asthma caregiver's quality of life questionnaire (pacqlq) at selected centers where a valid translation is available.

pediatric asthma clinical effectiveness study (peace). a randomized, double-blind, double dummy, parallel group comparative clinical study of salmeterol/fluticasone propionate inhalation powder (50/100mcg bid) via diskus† with oral montelukast (5mg qd) chewable tablets in children 6-14 years of age with persistent asthma

Eligibility criteria:
inclusion criteria: * diagnosis of asthma for at least 6 months (per american thoracic society \[ats\] definition). * best forced expiratory volume in one second (fev1) between 55% and 80% of predicted normal. * more than or 12% fev1 reversibility following inhalation of salbutamol. * must also be symptomatic on short-acting beta-agonists. * must not have used inhaled corticosteroids over the previous month or ltras (leukotriene antagonists)over the previous 2 weeks. exclusion criteria: * hospital admission for asthma within 3 months prior to visit 1. * sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding screening visit 1. * oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.

Keywords: persistent asthma pediatric asthmatic asthma control
oxaliplatin in unresectable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: primary: * to determine the tumor response rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of eloxatin+5-fluorouracil/leucovorin secondary: * safety and tolerability of this regimen in these patients


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed hepatocellular carcinoma * patients must have measurable disease by ct scan * patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy. * the period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. the prior chemotherapy should not include platinum compounds. * who performance status: 0 to 2 * patients must have adequate organ and marrow function as defined below: * leukocytes : ≥ 3,000/μl * absolute neutrophil count :≥ 1,500/μl * platelets : ≥ 80,000/μl * total bilirubin : \< 3.0g/dl * asat/alat : ≤ 3 times the upper normal limits of the institute * creatinine : \< 120μmol/l * patients with no evidence of clinically significant neuropathy. exclusion criteria: * documented allergy to platinum compound or to others study's drugs * pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception) * hematological disorder or malignancies * metastasis to central nervous system * other serious illness or medical conditions: * active infectious disease * congestive heart failure, or angina pectoris. previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia. * concurrent treatment with any other anticancer therapy * concurrent treatment with other experimental drugs. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
can food timing reduce your diabetes risk?

Conditions: Dietary Habits

Summary: the goal of this clinical trial is to test whether food timing impacts metabolic health in healthy participants. participants will: * complete 2 inpatient stays * be provided with test meals * have frequent blood draws

the investigators aim to investigate the influence of different food timing, without changing 24-h caloric and nutrient intake, on glucose and fat tolerance and energy expenditure in healthy people on a simulated day or night shift.

Eligibility criteria:
inclusion criteria: * healthy with no acute or chronic medical and psychiatric disorders * bmi: 18.5-29.9 kg/m2 exclusion criteria: * smokers, current tobacco or e-cigarette use * drug or alcohol dependency * pregnant

Keywords: glucose tolerance diet-induced thermogenesis fat tolerance
therapeutic and prognostic impact of circulating tumor cells in peripheral blood in patients with non small-cell lung cancer

Conditions: Circulating Tumor Cells

Summary: the purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

in spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. moreover, there are no markers for monitoring response to treatment. the objective of the study is to associate the number of circulating tumor cells (ctc) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: * histopathologic diagnosis of non small-cell lung cancer * clinical stage iv * ecog functional status 0 or 1 * no renal function alteration (gfr \>50%) * no hepatic function alteration (alt and ast less than 2 times its normal value) * leucocytes more than 2,000/mcl * hemoglobin more than 10mg/dl * platelets more than 100,000/mcl exclusion criteria: non-advanced disease

Keywords: non small-cell lung cancer circulating tumor cells carcinoembryonic antigen cytokeratin
evaluation of navigation assisted reconstruction of posttraumatic zygomatic deformity

Conditions: Zygomatic Fractures

Summary: treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge, even to the skilled surgeon. however, the development of computer-assisted navigation technology offers new opportunities in the treatment of such deformities. with the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. in this randomized controlled trial, the investigators would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

treatment of late deformities following fractures of the orbitozygomaticomaxillary complex can be considered a formidable challenge. even to the skilled surgeon, over-or underestimation of the displacement is likely to occur, leading to an unsatisfactory result caused by over- or undercorrection.however,the development of computer-assisted navigation technology offers new opportunities in the treatment of such deformities. with the help of navigation system,pre- and intraoperatively,the objective of any supporting medical device for reconstruction of the orbitozygomaticomaxillary complex would be visualization of the real and desired positions of the zygoma. in this randomized controlled trial, we would like to evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.

Eligibility criteria:
inclusion criteria: 1. post-traumatic unilateral deformities of the zygomaticomaxillary complex 2. the interval after the primary injury should be more than 21 days 3. meet the operation indication 4. voluntarily join this study with informed consents exclusion criteria: 1. obviously asymmetric of craniofacial structure 2. poor compliance of patient 3. any other condition that do not fit to participate in the study

Keywords: zygomatic fractures surgery, computer-assisted facial asymmetry